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Edwards PASCAL TrAnScatheter Valve RePair System Pivotal Clinical Trial (CLASP II TR): A prospective, multicenter, randomized, controlled pivotal trial to evaluate the safety and effectiveness of transcatheter tricuspid valve repair with the Edwards PASCAL Transcatheter Valve Repair System and optimal medical therapy (OMT) compared to OMT alone in patients with tricuspid regurgitation
CLASP II TR: Edwards PASCAL Transcatheter Valve Repair System Pivotal Clinical Trial in Patients with Tricuspid Regurgitation
Sponsor:Edwards Lifesciences LLC
Enrolling:Male and Female Patients
Minimum Age:18 years old
IRB Number:AAAS7556
U.S. Government ID:NCT04097145
Contact: Kate Dalton: 347-514-3366 /
Additional Study Information:

The goal of this early feasibility study is to gain initial insight into the basic safety and performance of transluminal (through the blood vessels) implantation of the PASCAL Systems implant (composed of man-made materials). We are trying to evaluate the safety and performance of the PASCAL System with Optimal Medical Therapy (OMT) (also known as standard of care) compared to OMT alone in participants withsymptomatic severe tricuspid regurgitation who may not be ideal candidates for tricuspid valve surgery (tricuspid valve repair that is performed via openheart surgery) and may be eligible for transcathetertricuspid valve repair.The PASCAL Transcatheter Valve Repair System is a research option for subjects who have Tricuspid Regurgitation (TR), which is a condition in which the hearts tricuspid valve does not close tightly which causes blood to flow backwards in the incorrect direction while the heart beats. Study subjects would be required to take antiplatelet medication (which stops blood cells (called platelets) from sticking together and forming a blood clot) after the procedure and as a result, would be at an increased risk for bleeding.

Do You Qualify?
Are you at least 18 years old?YesNo
Susheel Kodali, MD
You may be eligible for this study

Place Holder

Who Can I Contact?
For more information, please contact:
Kate Dalton
Phone: 347-514-3366